| CTRI Number |
CTRI/2022/02/040488 [Registered on: 22/02/2022] Trial Registered Prospectively |
| Last Modified On: |
24/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Experimental |
| Study Design |
Other |
|
Public Title of Study
|
Development of Chart which measures the Contrast sensitivity in moving letters |
|
Scientific Title of Study
|
Development of Dynamic Contrast Sensitivity Chart |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vandana Vighnesh Kamath |
| Designation |
Assistant Professor |
| Affiliation |
Sankara Eye Hospital,Bangalore |
| Address |
Sankara Eye Hospital
Varthur Main road,Kundalhalli Junction
Bangalore
KARNATAKA
560037
India |
| Phone |
09820541584 |
| Fax |
|
| Email |
vandu2388@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vandana Vighnesh Kamath |
| Designation |
Assistant Professor |
| Affiliation |
Sankara Eye Hospital,Bangalore |
| Address |
Sankara Eye Hospital
Varthur Main road,Kundalhalli Junction
Bangalore
KARNATAKA
560037
India |
| Phone |
09820541584 |
| Fax |
|
| Email |
vandu2388@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vandana Vighnesh Kamath |
| Designation |
Assistant Professor |
| Affiliation |
Sankara Eye Hospital,Bangalore |
| Address |
Sankara Eye Hospital
Varthur Main road,Kundalhalli Junction
Bangalore
KARNATAKA
560037
India |
| Phone |
09820541584 |
| Fax |
|
| Email |
vandu2388@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital,Varthur main road Bangalore |
|
|
Primary Sponsor
|
| Name |
Self sponser |
| Address |
Sankara college of optometry, banglore |
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vandana Kamath |
Sankara Eye Hospital |
Department of Optometry,Sankara college of Optometry,Second floor,Varthur Main road,Kundalhalli Junction
Bangalore
KARNATAKA |
09820541584
vandu2388@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE, Sankara Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normals |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with age group 17 – 30years
BCVA with 0.0 logMAR at distance, N6 at near
DVA – Equal or greater than 6/12 @ 45rpm
Emmetropes , Mild-Moderate refractive error
Myopia – SER (-1.0 to -6.0D)
Hypermetropia – SER (+1.0 to +5.0D) |
|
| ExclusionCriteria |
| Details |
Any ocular diseases / Active infection
- Media opacity
- Head, neck & ocular injury
- Vestibular problems
- Ambylopia
- Restricted ocular movements
- Poor eye pursuit & saccades |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To construct the dynamic contrast sensitivity chart |
Baseline and next day
Dynamic Visual acuity |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find Normative value for Dynamic contrast among young population |
baseline and next day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/02/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To construct and validate dynamic contrast chart Dynamic Contrast will be constructed and it will be compared with dynamic visual acuity and Pelirobson chart The normative value for dynamic contrast will be determined |